Description and Brand Names

US Brand Name

Endodan

Percodan

Descriptions

Oxycodone and aspirin combination is used to relieve moderate to moderately severe pain. Oxycodone belongs to the group of medicines called narcotic analgesics (pain medicines). It acts on the central nervous system (CNS) to relieve pain.

Aspirin is used to relieve pain and reduce fever in patients. Aspirin belongs to the group of medicines known as salicylates and acts on the immune system to reduce inflammation. It is also known as an anti-inflammatory analgesic.

When oxycodone is used for a long time, it may become habit-forming, causing mental or physical dependence. However, people who have continuing pain should not let the fear of dependence keep them from using narcotics to relieve their pain. Mental dependence (addiction) is not likely to occur when narcotics are used for this purpose. Physical dependence may lead to withdrawal side effects if treatment is stopped suddenly. However, severe withdrawal side effects can usually be prevented by gradually reducing the dose over a period of time before treatment is stopped completely.

This medicine is available only with your doctor's prescription.

This product is available in the following dosage forms:

Tablet

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of oxycodone and aspirin combination in the pediatric population. Because of aspirin's toxicity, use in children and teenagers is not recommended.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of oxycodone and aspirin combination in the elderly. However, elderly patients are more likely to have age-related liver or kidney problems, which may require caution and an adjustment in the dose for patients receiving oxycodone and aspirin combination.

Pregnancy

Information about this oxycodone-and-aspirin-oral-route

Pregnancy Category

Explanation

All Trimesters

D

Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breastfeeding

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Breastfeeding

Breastfeeding

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Influenza Virus Vaccine, Live

Ketorolac

Naltrexone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Abciximab

Abiraterone Acetate

Acenocoumarol

Acepromazine

Alfentanil

Alipogene Tiparvovec

Alprazolam

Alteplase, Recombinant

Alvimopan

Amiodarone

Amisulpride

Amprenavir

Anagrelide

Anileridine

Anisindione

Apixaban

Aprepitant

Ardeparin

Argatroban

Aripiprazole

Asenapine

Atazanavir

Baclofen

Benperidol

Beta Glucan

Bivalirudin

Boceprevir

Brofaromine

Bromazepam

Buprenorphine

Buspirone

Butorphanol

Carisoprodol

Carphenazine

Ceritinib

Certoparin

Chloral Hydrate

Chlordiazepoxide

Chlorpromazine

Chlorzoxazone

Cilostazol

Citalopram

Clarithromycin

Clobazam

Clonazepam

Clopidogrel

Clorazepate

Clorgyline

Clovoxamine

Clozapine

Cobicistat

Codeine

Conivaptan

Crizotinib

Cyclobenzaprine

Cyclosporine

Dabigatran Etexilate

Dabrafenib

Dalteparin

Danaparoid

Darunavir

Delavirdine

Desirudin

Desvenlafaxine

Dexmedetomidine

Dezocine

Diacetylmorphine

Diazepam

Dichloralphenazone

Dicumarol

Difenoxin

Dihydrocodeine

Diphenhydramine

Diphenoxylate

Dipyridamole

Dipyrone

Doxylamine

Droperidol

Duloxetine

Enflurane

Enoxaparin

Eptifibatide

Erlotinib

Erythromycin

Escitalopram

Eslicarbazepine Acetate

Estazolam

Eszopiclone

Ethchlorvynol

Ethopropazine

Ethylmorphine

Etomidate

Femoxetine

Fentanyl

Feverfew

Flesinoxan

Flunitrazepam

Fluoxetine

Fluphenazine

Flurazepam

Fluspirilene

Fluvoxamine

Fondaparinux

Fosaprepitant

Fospropofol

Furazolidone

Ginkgo

Gossypol

Halazepam

Haloperidol

Halothane

Heparin

Hexobarbital

Hydrocodone

Hydromorphone

Hydroxyzine

Idelalisib

Imatinib

Indinavir

Iproniazid

Isocarboxazid

Isoflurane

Itraconazole

Ketamine

Ketazolam

Ketobemidone

Ketoconazole

Ketoprofen

Lazabemide

Lepirudin

Levomilnacipran

Levorphanol

Linezolid

Lomitapide

Loprazolam

Lorazepam

Lormetazepam

Meadowsweet

Meclizine

Medazepam

Melperone

Meperidine

Meptazinol

Mesoridazine

Metaxalone

Methadone

Methdilazine

Methocarbamol

Methohexital

Methotrexate

Methotrimeprazine

Methylene Blue

Methylnaltrexone

Midazolam

Mifepristone

Milnacipran

Mitotane

Moclobemide

Molindone

Moricizine

Morphine

Morphine Sulfate Liposome

Nadroparin

Nalbuphine

Nalmefene

Nalorphine

Naloxegol

Naloxone

Naproxen

Nefazodone

Nelfinavir

Nialamide

Nicomorphine

Nilotinib

Nitrazepam

Nitrous Oxide

Olanzapine

Opium

Orphenadrine

Oxazepam

Oxycodone

Oxymorphone

Papaveretum

Paregoric

Pargyline

Parnaparin

Paroxetine

Pemetrexed

Pentazocine

Pentosan Polysulfate Sodium

Pentoxifylline

Perazine

Periciazine

Perphenazine

Phenelzine

Phenindione

Phenprocoumon

Pimozide

Piperacetazine

Piperaquine

Pipotiazine

Piritramide

Posaconazole

Pralatrexate

Prasugrel

Prazepam

Procarbazine

Prochlorperazine

Promazine

Promethazine

Propofol

Propoxyphene

Protein C

Quazepam

Quetiapine

Ramelteon

Rasagiline

Regorafenib

Remifentanil

Remoxipride

Reteplase, Recombinant

Reviparin

Ritonavir

Rivaroxaban

Samidorphan

Saquinavir

Selegiline

Sertindole

Sertraline

Sibutramine

Siltuximab

Sodium Oxybate

Sufentanil

Sulpiride

Suvorexant

Tacrolimus

Tapentadol

Telaprevir

Telithromycin

Temazepam

Thiopropazate

Thioridazine

Ticagrelor

Ticlopidine

Tilidine

Tinzaparin

Tirofiban

Tizanidine

Tolonium Chloride

Toloxatone

Topiramate

Tramadol

Tranylcypromine

Treprostinil

Triazolam

Trifluoperazine

Trifluperidol

Triflupromazine

Trimeprazine

Varicella Virus Vaccine

Venlafaxine

Vilazodone

Vortioxetine

Warfarin

Zaleplon

Zimeldine

Zolpidem

Zopiclone

Zotepine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acebutolol

Acetohexamide

Alacepril

Alprenolol

Amiloride

Amlodipine

Arotinolol

Atenolol

Azilsartan Medoxomil

Azosemide

Befunolol

Bemetizide

Benazepril

Bendroflumethiazide

Benzthiazide

Bepridil

Betamethasone

Betaxolol

Bevantolol

Bisoprolol

Bopindolol

Bucindolol

Bumetanide

Bupranolol

Buthiazide

Candesartan Cilexetil

Canrenoate

Captopril

Carteolol

Carvedilol

Celecoxib

Celiprolol

Chlorothiazide

Chlorpropamide

Chlorthalidone

Cilazapril

Clopamide

Cortisone

Cyclopenthiazide

Deflazacort

Delapril

Dexamethasone

Dilevalol

Diltiazem

Enalaprilat

Enalapril Maleate

Eprosartan

Esmolol

Ethacrynic Acid

Felodipine

Flunarizine

Fosinopril

Furosemide

Gallopamil

Gliclazide

Glimepiride

Glipizide

Gliquidone

Glyburide

Hydrochlorothiazide

Hydroflumethiazide

Ibuprofen

Imidapril

Indapamide

Irbesartan

Isradipine

Labetalol

Lacidipine

Landiolol

Levobunolol

Lidoflazine

Lisinopril

Losartan

Manidipine

Mepindolol

Methyclothiazide

Methylprednisolone

Metipranolol

Metolazone

Metoprolol

Miconazole

Moexipril

Nadolol

Nebivolol

Nicardipine

Nifedipine

Nilvadipine

Nimodipine

Nipradilol

Nisoldipine

Nitrendipine

Nitroglycerin

Olmesartan Medoxomil

Oxprenolol

Paramethasone

Penbutolol

Pentopril

Perampanel

Perindopril

Pindolol

Piretanide

Polythiazide

Pranidipine

Prednisolone

Prednisone

Probenecid

Propranolol

Quinapril

Ramipril

Rifampin

Rofecoxib

Sotalol

Spirapril

Spironolactone

St John's Wort

Streptokinase

Talinolol

Tamarind

Tasosartan

Telmisartan

Temocapril

Tenecteplase

Tertatolol

Timolol

Tolazamide

Tolbutamide

Torsemide

Trandolapril

Triamcinolone

Triamterene

Trichlormethiazide

Valproic Acid

Valsartan

Verapamil

Voriconazole

Xipamide

Zofenopril

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

Ethanol

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

Ethanol

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Addison's disease (adrenal gland problem) or

Alcohol abuse, or history of or

Bleeding problems or

Brain tumor, history of or

Chronic obstructive pulmonary disease (COPD) or

Cor pulmonale (serious heart condition) or

Drug dependence, especially with narcotics, or history of or

Enlarged prostate (BPH, prostatic hypertrophy) or

Gallbladder disease or gallstones or

Head injuries, history of or

Hypothyroidism (an underactive thyroid) or

Hypovolemia (low blood volume) or

Kyphoscoliosis (curvature of the spine with breathing problems) or

Peptic ulcer disease, active or history of or

Problems with passing urine or

Vitamin K deficiency—Use with caution. May increase risk for more serious side effects.

Asthma with nasal polyps and rhinitis, history of or

Asthma, severe or

Breathing problems, severe (e.g., hypoxia) or

Hemophilia (a bleeding problem) or

Paralytic ileus (intestine stops working and may be blocked) or

Respiratory depression (very slow breathing)—Should not be used in patients with these conditions.

Hypotension (low blood pressure) or

Pancreatitis (inflammation of the pancreas) or

Seizures, history of—Use with caution. May make these conditions worse.

Kidney disease or

Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. This is especially important for elderly patients, who may be more sensitive to the effects of pain medicines. If too much of this medicine is taken for a long time, it may become habit-forming (causing mental or physical dependence).

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage form (tablets):

For moderate to moderately severe pain:

Adults—One tablet every 6 hours as needed. Your doctor may adjust your dose if needed. However, the dose is usually not more than 12 tablets per day.

Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Flush the unused Percodan® oral tablets down the toilet.

Precautions

It is very important that your doctor check your progress while you are taking this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that can make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds; sedatives, tranquilizers, or sleeping medicine; other prescription pain medicine or narcotics; medicine for seizures or barbiturates; muscle relaxants; or anesthetics, including some dental anesthetics. Also, there may be a higher risk of bleeding problems if you drink three or more alcoholic beverages per day while you are taking aspirin. Do not drink alcoholic beverages, and check with your doctor before taking any of these medicines while you are using this medicine.

This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.

Dizziness, lightheadedness, or fainting may occur when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem. Also, lying down for a while may relieve the dizziness or lightheadedness.

This medicine may make you dizzy, drowsy, or lightheaded. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.

Using narcotics for a long time can cause severe constipation. To prevent this, your doctor may direct you to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems.

Check with your doctor right away if you have the following symptoms while using this medicine: acid or sour stomach; bloody or black, tarry stools; heartburn; nausea; vomiting; stomach pain; or vomiting of blood or material that looks like coffee grounds.

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth while you are using this medicine.

If you have been using this medicine regularly for several weeks or longer, do not change your dose or suddenly stop using it without checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help prevent worsening of your condition and reduce the possibility of withdrawal symptoms, such as abdominal or stomach cramps, anxiety, fever, nausea, runny nose, sweating, tremors, or trouble with sleeping.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

pains in the stomach, side, or abdomen, possibly radiating to the back

pale skin

pinpoint red or purple spots on the skin

prolonged bleeding from cuts

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

red or black, tarry stools or dark urine

restlessness

shivering

shortness of breath

skin rash

sleepiness

sunken eyes

sweating

swelling of face, ankles, hands, feet, or lower legs

thirst

tightness in the chest

unusual bleeding or bruising

unusual tiredness or weakness

vomiting of material that looks like coffee grounds, severe and continuing

weak or feeble pulse

weakness or heaviness of the legs

weight gain

wheezing

wrinkled skin

yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Continuing ringing or buzzing or other unexplained noise in the ears

decreased awareness or responsiveness

diarrhea

drowsiness

enlarged pupils

extremely high fever or body temperature

fast, weak heartbeat

hearing loss

increase in heart rate

restlessness

severe sleepiness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

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